Manager, Regulatory Affairs- Strategic Alliances
Medtronic · Lafayette, Colorado, United States
We anticipate the application window for this opening will close on - 12 Nov 2026
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the LifeThe Manager, Regulatory Affairs - Strategic Alliances leads regulatory support for ACM strategic alliance partners and serves as a primary regulatory interface across the partnership lifecycle. This leader translates commercial agreements and partner product roadmaps into global regulatory strategies and executable registration plans; coordinates execution through product design and regional Regulatory Affairs teams; enables accurate and timely partner communications; supports partner documentation requests and health authority questions; and drives resolution of complex integration, change, and market-access challenges. The Manager leads one direct report while delivering outcomes through broad cross-functional and regional influence. Demonstrated expertise in project or program management is highly valued in this role.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
Partner Regulatory Strategy & Registration Planning
- Serve as the named Regulatory Affairs point of contact for assigned strategic alliance partners, developing trusted relationships and maintaining continuity of agreement context, product history, and regulatory commitments.
- Translate partnership agreements, commercial priorities, product roadmaps, technical integration plans, and launch objectives into global regulatory strategies, milestones, dependencies, and executable registration plans.
- Clarify Medtronic and partner regulatory roles, deliverables, decision rights, documentation expectations, and escalation pathways for each program and market.
- Identify regulatory risks, sequencing constraints, and market-access opportunities early enough to influence product, evidence, investment, integration, and launch decisions.
- Maintain forward-looking registration roadmaps and forecasts that align partner demand with regional capacity, product readiness, and business priorities.
Global Execution, Monitoring & Partner Updates
- Drive execution of agreed registration plans through product design and regional Regulatory Affairs teams and cross-functional partners, without duplicating regional submission ownership.
- Establish operating rhythms, trackers, milestones, dashboards, and governance forums that provide clear visibility to progress, upcoming decisions, risks, and overdue actions.
- Provide partners with accurate, timely, and audience-appropriate updates on registration status, constraints, decisions, and recovery plans.
- Anticipate execution gaps, escalate issues with clear options and recommendations, and coordinate accountable action plans through closure.
- Monitor performance and use lessons learned to improve forecasting, planning accuracy, responsiveness, and partner experience.
Partner Portal, Documentation & Health Authority Support
- Own the Regulatory Affairs intake, triage, prioritization, and coordination of partner portal requests for registration documentation and regulatory information.
- Coordinate with product, regional, quality, clinical, engineering, operations, legal, and other subject matter experts to provide complete, consistent, controlled, and timely responses.
- Support partners as they pursue global registrations, including responding to questions from health authorities and coordinating supplemental documentation or technical clarification.
- Maintain request records, documentation traceability, partner-specific knowledge, and appropriate access controls within the portal and related systems.
- Identify recurring requests and develop standardized content, guidance, or self-service solutions that improve efficiency while protecting compliance and confidential information.
Issue Resolution, Change Assessment & Integration Support
- Lead cross-functional troubleshooting when partner registrations or integrations encounter barriers, ambiguity, or misalignment.
- Coordinate resolution of issues involving product release readiness, system configuration, regulatory data, documentation inconsistencies, submission dependencies, and regional requirements.
- Assess or coordinate regulatory impact assessments for product and process changes, partner product change notifications, evolving regulations and standards, and sustaining activities.
- Facilitate fact-based decisions across Medtronic, partner, and regional stakeholders; document decisions, owners, actions, and residual risks.
- Escalate significant compliance, contractual, market-access, timeline, or business-continuity risks to the appropriate governance body.
People & Stakeholder Leadership
- Lead, coach, and develop one direct report, establishing clear responsibilities, priorities, performance expectations, and development objectives.
- Allocate work between the leader and direct report based on partner complexity, risk, business priority, and capability development needs.
- Build strong relationships with Strategic Alliance Sales, Quality, R&D, Operations, Marketing, Legal, Supply Chain, and partner organizations.
- Communicate complex regulatory topics clearly across executive, partner, regional, and technical audiences and influence outcomes without relying on formal authority.
- Promote an inclusive, accountable, responsive, and continuous-improvement culture focused on partner commitments, patient access, and compliant execution.
Must Have: Minimum Requirements
- Baccalaureate degree in science, engineering, regulatory affairs, or a related discipline and a minimum of 5 years of relevant experience, including 3+ years of leadership experience demonstrated through direct management and/or significant mentorship or advisory responsibility; or an advanced degree with a minimum of 3 years of relevant experience, including 3+ years of leadership experience.
- Demonstrated medical device regulatory experience supporting global registrations, product lifecycle activities, product changes, or market-access programs.
- Experience leading complex, cross-functional programs in a regulated, global, and matrixed environment.
- Experience translating strategy into structured plans, milestones, governance, risk management, and consistent execution.
- Ability to communicate and influence effectively with internal leaders, regional teams, technical experts, and external business partners.
Nice to Have
- Advanced degree in science, engineering, regulatory affairs, business, law, or a related discipline.
- Experience supporting OEM, distributor, licensing, co-development, integration, or other strategic alliance business models.
- Experience developing global regulatory strategies and coordinating registrations across multiple international markets.
- Experience managing partner portals, request-management processes, controlled documentation, regulatory information systems, dashboards, or workflow tools.
- Experience assessing product changes, product change notifications, system or configuration changes, standards transitions, and documentation discrepancies.
- Working knowledge of design controls, product release, quality systems, labeling, and post-market regulatory obligations.
- Strong business acumen, customer orientation, negotiation, conflict resolution, presentation, and executive communication skills.
- Demonstrated success developing talent and improving team operating mechanisms.
For Baccalaureate degrees earned outsi